Corea Hospital Company
✅ Low Risk
FEI: 3012292417 • Gumapo-Gu • SOUTH KOREA
FEI Number
3012292417
Location
Gumapo-Gu
Country
SOUTH KOREAAddress
Kimpho Hankang 3 Ro 283 B1 Newcorea, Mapo, Gumapo-Gu, , South Korea
Low Risk
FDA Import Risk Assessment
This firm has a minimal history of FDA import refusals with low-severity violations.
Statistics
Score Breakdown
How is this score calculated?
Proprietary Algorithm
- 40% Violation Severity — AI-assessed (1-10)
- 30% Refusal Volume — Logarithmic scale
- 20% Recency — Decays over 5 years
- 10% Frequency — Refusals per year
© ImportRefusal.com Original Analysis
Violation Summary
NOT LISTED
It appears the drug or device is not included in a list required by Section 510(j), or a notice or other information respecting it was not provided as required by section 510(j) or 510(k).
LACKS FIRM
The article is in package form and appears to not bear a label containing the name and place of business of the manufacturer, packer, or distributor.
REGISTERED
It appears the device is subject to listing under 510(j) and the initial distributor has not registered as required by 21 CFR 807.20 (a)(5).
Refusal History
Frequently Asked Questions
What is Corea Hospital Company's FDA import refusal history?
Corea Hospital Company (FEI: 3012292417) has 1 FDA import refusal record(s) in our database, spanning from 6/3/2016 to 6/3/2016.
What is an FEI number?
FEI stands for Firm Establishment Identifier. It's a unique number assigned by the FDA to identify establishments that manufacture, process, pack, or hold food, drugs, medical devices, or other FDA-regulated products. Corea Hospital Company's FEI number is 3012292417.
What types of violations has Corea Hospital Company received?
Corea Hospital Company has been cited for 3 different violation type(s). Common FDA violations include adulteration (unsafe or unsanitary products), misbranding (incorrect or misleading labels), and regulatory non-compliance.
Where does this information about Corea Hospital Company come from?
All FDA import refusal data for Corea Hospital Company is sourced from the official FDA Data Dashboard (datadashboard.fda.gov), a public government database maintained by the U.S. Food and Drug Administration.
Data sourced from the FDA Data Dashboard, a public database maintained by the U.S. Food and Drug Administration.